Select Committee on Health Written Evidence


APPENDIX 35

Memorandum by the Prescription Medicines Code of Practice Authority (PI 128)

RESPONSE TO THE ANALYSIS OF THE PHARMACEUTICAL INDUSTRY'S MARKETING DOCUMENTS

  The Analysis of the Pharmaceutical Industry's Marketing Documents provided to the House of Commons Health Select Committee refers to examples which the authors consider contravene the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry.

  The Prescription Medicines Code of Practice Authority (PMCPA) has not seen the materials submitted by the five companies, much of which was internal documentation not for use with either health professionals or the public. The Code applies to the promotion of medicines for prescribing to health professionals and to appropriate administrative staff and to information made available to the public about medicines so promoted (Clause 1.1). Internal documentation is not usually covered by the Code. It appears that much of the material criticised is internal documentation.

  The PMCPA does not know whether the materials requested have already been the subject of complaints under the Code. It appears from the limited details in the Analysis that some of the criticisms may relate to matters previously the subject of complaints under the Code. Most of the products listed have been the subject of complaints over the last couple of years, with some ruled to be in breach of the Code. In every case where a breach is ruled the practice in question has to cease forthwith and a detailed report is published.

  The Analysis draws unsubstantiated conclusions from activities and misunderstands the requirements of the Code in that it gives the impression that every activity that increases sales of a specific medicine is a breach of the Code. This is simply not so.

  When considering whether or not there has been a breach of the Code the most important considerations are the content of the material actually used with the health professional or member of the public and its effect. As in the interpretation of UK law, the intention of the material/activity is not necessarily relevant although it might be taken into account when trying to decide whether high standards have been maintained (Clause 9.1) or whether there is a reduction in confidence in the industry (Clause 2) or when determining the sanctions to be applied if a breach of the Code is ruled.

  It appears from the Analysis that there have been many misunderstandings about what is permitted by the Code and what is not. Detailed comments appear below.

A.  GENERAL PUBLIC

  Medicines can be named in information made available to the public provided such material complies with Clause 20 of the Code including the prohibition on advertising prescription only medicines and certain other medicines to the public.

  1.  It is not a breach of the Code to target members of the public (even those that are likely to respond to the message) nor is it a breach of the Code to segment the population. The important point is whether the materials used with the public are in accordance with Clause 20 of the Code.

  2.  It is not a breach of the Code for a company to carry out its activities in such a way that the public is more receptive to the message, for example by working with patient organisations to produce materials or leaving leaflets in pharmacies and/or surgeries. The content of the material is the important factor, including the requirement to clearly declare sponsorship on materials relating to medicines and their uses (Clause 9.10).

  3.  Companies may make reference to direct to consumer advertising as some medicines which are promoted to health professionals for prescribing can also be legally advertised to the public for purchase (over-the-counter medicines). Public relations activities to the public are covered by Clause 20. Placing articles in the lay press, TV documentaries, soap operas etc is not necessarily in breach of the Code. This would depend on whether the material provided by the company to the press, TV company etc complied with the Code.

  4.  It is not necessarily a breach of the Code to run advertising campaigns in the national press; this would depend on the content. A legitimate disease awareness campaign might be referred to by a company as advertising even though it does not mention directly or indirectly any medicine at all.

  5.  Aiming a campaign at those most likely to take action does not in itself suggest that the campaign is primarily concerned with those who are most likely to benefit the company.

  6.  A legitimate disease awareness campaign that was in accordance with the Code (which would mean it was also in accordance with the Medicines and Healthcare products Regulatory Agency guidance) would be acceptable even though it resulted in increased prescription of the company's product.

  7.  If material for the public complies with Clauses 20.1 and 20.2 of the Code, including the need for it to be factual, balanced information that is not going to raise unfounded hopes of successful treatment or be misleading with respect to the safely of the medicine and for it not to encourage members of the public to ask their doctors to prescribe a specific medicine, then the use of "emotional" messages is not in conflict with the requirements of Clause 20 of the Code.

B.  HEALTH PROFESSIONALS

  The Analysis does not mention the requirements of Clauses 7.4 and 7.5 that all information claims or comparisons must be capable of substantiation and that such substantiation must be provided without delay following a request from a health professional or appropriate administrative staff. Nor does it mention that the promotion of a medicine prior to the grant of the marketing authorisation is prohibited by Clause 3.

  1.  If promotion to health professionals and appropriate administrative staff complies with the Code then the use of "emotional" messages is not a breach of the Code.

  2.  Companies can provide certain information prior to the grant of the marketing authorisation provided the information is not promotional for that medicine.

  3.  A message to health professionals, appropriate administrative staff or patients that a medicine is "safe" would be a breach of the Code (Clauses 7.9 and 20.2). Information about side effects that reflects available evidence and is capable of substantiation can be provided.

  4.  Companies can prepare responses to media enquiries. Such responses must comply with the Code.

  5.  Companies have been ruled in breach of Clause 9.3 for using health professionals to advertise medicines. Companies can use key opinion leaders to present at meetings etc. The involvement of the pharmaceutical company should be made clear and messages from key opinion leaders employed by companies are subject to the Code. Honoraria payments for health professionals should be in line with BMA suggested rates or similar.

CONCLUSION

  The only bodies that can decide whether material or activities are in breach of the Code are the Code of Practice Panel and the Code of Practice Appeal Board. Bearing in mind the above comments if details of the specific criticisms were provided to the PMCPA, then the matters could be dealt with as complaints under the Code.

  The Code is reviewed approximately every two to three years. The ABPI is currently undertaking a review of the Code and its operation including consultation with stakeholders and others.





 
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Prepared 26 April 2005